Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

One of the fastest growing medical markets with great potential, regenerative medicine treats chronic diseases that were once untreatable. Therapy using live cells is increasingly used to replace damaged tissue, deliver gene therapies to target tissues and organs, and stimulate self-healing along with a number of other applications. View the full article below – Login Required Reference 1 Regenerative Medicines Market: Global Opportunity Analysis and Industry Forecast, 2015–2022. Allied Market Research: Pune,Maharashtra, India: August 2016; www.alliedmarketresearch.com/regenerative-medicines-market. 2 Chartrain NA, Williams…

Single-use technology (SUT) has been adopted on a global scale since its introduction 20 years ago. Its benefits are well-recognized, and it is a key enabling technology in today’s biopharm world. Thousands of single-use products are now on the market and entire processes are being run in single-use systems. Historically, end users have been encouraged to produce ‘customized’ single-use solutions for each individual application. While this can give the user exactly what they want, it can be at the expense…

It is well recognized that the cost of Protein A resins is substantial. If a product makes it to marketing approval and manufacturing the high cost is amortized over a large number of purification cycles then the contribution to cost of goods is acceptable. However, a high percentage of clinical projects will fail and the Protein A resin will only be used for a small number of cycles. One way to address this issue is to use a less expensive…

The implementation of single-use technologies for pharmaceutical product development continues to gain momentum; this trend is due to the advantages of increased flexibility, speed of implementation and lower capital investment. In particular, they are seen as a means to accelerate the production of material for clinical trials. However, a primary concern regarding the use of such technologies is the impact and level of leachables in the final drug substance. Typically this concern is addressed through a risk assessment utilizing extractable…

The downstream purification process of any biologic has several objectives: purity, yield, and safety for humans or animals. A critical component of safety assurance is reducing virus to levels that meet stringent regulatory requirements. Virus reduction can be achieved through multiple complementary approaches and most processes rely on a combination of technologies that are designed primarily to achieve purification targets, but may also offer opportunities for virus reduction. The purpose of this project was to establish capabilities for producing a…

Improvements in upstream process development often generate complex, high titer process streams, placing considerable demands on downstream processing steps. Protein aggregates in these feeds influence hydraulic performance of virus filters resulting in over-sized platforms and a significant impact on process economics. Virus filters from a broad range of manufactures provide robust viral clearance but the impact of aggregates on flux is dependent on the filter. The impact of conditioning protein solutions using prefiltration was assessed with several monoclonal antibody feed…

Current trends in the bioprocessing industry are driving mAb and plasma producers to formulate at higher protein concentrations. As a result, formulating using tangential flow filtration (TFF) may be limited in reaching these concentrations due to high pressures caused by highly viscous feed streams. Filtration devices used during processing have to be optimized in order to handle both high viscosity and pressures while maintaining high flux and excellent product recovery. In this study, a family of filtration devices was evaluated…

Continuous process optimization is a key factor in the biotech in-dustry. With higher and higher particle loads (>108 cells/ml), standard technologies for cell removal (midstream processing) – e.g. centrifugation, separation, membrane- and depth filtration – find their limits. The goal of the following study was to focus on making the midstream process more economical and investigate the efficiency increase for the cleaning of fermentation broths through alluvial filtration (see box) and its ease of scalability. This technology leads to a…